New Anti-Angiogenesis Agent Found To Be Safe In Initial Tests In Cancer Patients

INDIANAPOLIS -- A new anti-angiogenesis agent has proven to be safe in the treatment of patients with various forms of metastatic cancer, researchers at Indiana University School of Medicine reported Monday, May 18, at the annual meeting of the American Society of Clinical Oncologists in Los Angeles.

Michael S. Gordon, M.D., associate professor and principal investigator of the Phase I trial, said, “The new agent, anti-VEGF antibody, was well tolerated in our initial trial. Adverse effects were mild and limited to symptoms such as headache and low-grade fever in a limited number of the trial participants.”

The Phase I trial assessed the safety of the new agent, called anti-vascular endothelial growth factor (rhuMAb VEGF or anti-VEGF antibody), on 25 adult patients at doses ranging from 0.1 to 10.0 mg/kg/dose. The agent was administered intravenously over 90 minutes once during the first month of therapy and weekly for three consecutive weeks in the second month of treatment. One of those patients with renal cell cancer showed a 39 percent reduction in tumor size. An additional 13 patients had stable disease at the end of the study period.

Since safety was shown in the Phase I trial, early Phase II clinical trials are beginning studying patients with various types of solid tumors who meet the eligibility criteria.

Despite advancements made in chemotherapy, some tumor types are unresponsive to even the most aggressive chemotherapy agents. In pre-clinical trials, the anti-VEGF antibody resulted in a decline in the growth and metastasis in a variety of these chemotherapy-resistant solid tumors.

Angiogenesis is the formation of new blood vessels. Anti-angiogenesis is the inhibition of new blood vessel formation. Research has shown that cancerous tumors need blood supply to grow and metastasize.

VEGF is a protein that is secreted from blood-deprived tissues and from some types of malignant cells. VEGF regulates angiogenesis by binding to specific receptors on nearby blood vessels, causing new vessels to form. Anti-VEGF antibody, a recombinant humanized monoclonal antibody, has the ability to inhibit this effect by preventing VEGF from binding to its receptors.

The anti-VEGF antibody was developed at and the study was sponsored by Genentech, Inc. of South San Francisco, Calif. Two other institutions, M.D. Anderson Cancer Center in Houston, Texas, and City of Hope Medical Center in Los Angeles, were involved in the Phase I study.

Contact: Mary Hardin
317-274-7722
mhardin@iupui.edu

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